Trial Search Results

ARrest RESpiraTory Failure From PNEUMONIA

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institutes of Health (NIH)

Intervention(s):

  • Drug: Inhaled budesonide and formoterol
  • Drug: Inhaled placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Severe Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms
   (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest
   radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or >
   38oC or WBC > or < upper or lower limits for site or procalcitonin > 0.5 mcg/L), or
   known current immunosuppression preventing inflammatory response.

and

   - Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room
   air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.

and

   - No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2
   infection.

Exclusion Criteria:

   - Inability to obtain consent within 24 hours of presentation to emergency room

   - Intubation (or impending intubation) prior to enrollment (This does not include those
   patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation
   (NIV) prior to enrollment)

   - A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic
   steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients
   receiving inhaled beta-agonists in the Emergency Department without an established
   indication if treating clinician is willing to discontinue subsequent treatments)

   - Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical
   ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation
   syndrome

   - Not anticipated to survive > 48 hours or not expected to require > 48 hours of
   hospitalization

   - Contraindication or known allergy to inhaled corticosteroids or beta-agonists

   - Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular
   tachycardia within last 4 hours will be potentially eligible for enrollment after the
   condition has resolved

   - Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition
   has resolved

   - Patient not committed to full support other than intubation or resuscitation (i.e.,
   DNR/DNI status allowed)

   - Pregnancy

   - Incarcerated individual

   - Physician refusal of consent to protocol

   - Patient/surrogate refusal of consent to protocol

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joe Levitt, MD
650-723-6381